MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Paralysis (1997)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

During a clinical trial, sponsored by biosense webster, inc., it was reported that a (b)(6) female ((b)(6)) patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a diaphragmatic paralysis.The procedure occurred on (b)(6) 2020.The ablation catheter was inserted in the patient.The procedure was completed successfully.It was reported that a diaphragmatic paralysis occurred on (b)(6) 2020.Per the study, it was non-serious.It was not device related and it was procedure related.Resolution of diaphragmatic paralysis was on (b)(6) 2020.The physician¿s opinion on the cause of this adverse event was that it was procedure related.Patient outcome was reported as fully recovered.A smart touch sf catheter was used in this procedure.Multiple attempts have been made to obtain the specific product used.However, the product number is unknown.Therefore, the product of unk_smart touch bidirectional sf was used.

Manufacturer Narrative

Additional information was received on 01-jul-2021 providing the ¿e1.Initial reporter facility name.¿ therefore, processed this field.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 26-jul-2021, observed a correction to 3500a follow-up #1 as (b)(6) hospital was omitted from e.Initial reporter facility name.Therefore, processed this field.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12038123
• MDR Text Key: 262634649
• Report Number: 2029046-2021-00962
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: SMART TOUCH BIDIRECTIONAL CATH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 46